Process Engineer (Process Development Engineer)

Job Title: Process Engineer (Process Development Engineer)Location: Tucson, AZThis is an onsite position for a Process Engineer in the Manufacturing Operations department.Required Education & Experience--Bachelor's Degree (required), preferably in Engineering/Engineering Technology or a Life Science discipline.--2-5 years of relevant work experience.--Basic knowledge of GMP and regulatory standards.--Strong analytical and problem-solving skills.--Excellent communication and teamwork abilities.--Knowledge of Lean principles and/or Six Sigma methodologies (preferred).The Opportunity--Focus on continuous improvement, design, automation, cGMP compliance, and quality management within manufacturing processes.--Lead Lean Manufacturing initiatives to enhance efficiency and effectiveness.Key ResponsibilitiesProcess Engineering & Improvement (60%)--Design, develop, and improve manufacturing processes for new and existing products (aiming for reduced cycle time).--Analyze process data and perform troubleshooting to resolve technical issues and decrease downtime.--Design and implement automation solutions to streamline processes.--Support process validation and qualification activities.--Utilize process simulation software and engineering tools for optimization.--Manage project timelines for equipment repairs, maintenance, and upgrades.Compliance & Quality (10%)--Ensure strict adherence to current Good Manufacturing Practices (cGMP) and internal quality standards.--Maintain documentation (flow diagrams, work instructions, reports).--Conduct risk assessments and develop mitigation strategies.--Assist in audit readiness and Non-Conformance Report (Client) investigations.--Identify and escalate potential safety hazards.Continuous Improvement (30%)--Apply Lean principles to eliminate inefficiencies and waste.--Use problem-solving methodologies (e.g., Five Whys, Fishbone diagrams) for root cause analysis.--Use statistical tools (e.g., Minitab) to analyze data and generate actionable insights.--Establish and maintain Overall Equipment Effectiveness (OEE) improvement plans and track performance metrics.--Develop and maintain standardized procedures and documentation.Maintenance--Develop and implement comprehensive preventive maintenance plans for manufacturing and test equipment.--Coordinate with maintenance teams for scheduled maintenance, service, and calibrations.